This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the urological exclusion from the "indications for use" statement. The device, as modified, will be marketed under the trade names costasis/dynastat surgical hemostat and is indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to the hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
| Device | COSTASIS/DYNASTAT SURGICAL HEMOSTATS |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES |
| Date Received | 2001-12-27 |
| Decision Date | 2002-03-14 |
| PMA | P990030 |
| Supplement | S003 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES 3600 S.w 47th Avenue gainesville, FL 32608 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990030 | Original Filing | |
| S005 | 2004-08-23 | Normal 180 Day Track No User Fee |
| S004 | 2002-04-30 | Normal 180 Day Track |
| S003 | 2001-12-27 | Normal 180 Day Track |
| S002 | 2001-11-20 | Special (immediate Track) |
| S001 | 2000-10-18 | Real-time Process |